Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy

Not Applicable

Recruiting

• Conditions: Spastic Cerebral Palsy; Spasticity as Sequela of Stroke; Spasticity, Muscle
• Interventions: Other: Sham; Radiation: stereotactic radiosurgery (SRS) dorsal root rhizotomy radiomodulation

• Registration Number: NCT06070233
• Lead Sponsor: Ohio State University

Brief Summary

A scientific study is being done to test a special treatment for people who have spasticity or tight muscles. This treatment is called "stereotactic radiosurgery dorsal rhizotomy." It uses very accurate beams of radiation to target certain nerves in the back to help loosen up the muscles. In this study, people are put into two groups by chance: one group gets the real treatment, and the other group gets a "fake" treatment that doesn't do anything. This fake treatment is called a "sham." Doing this helps make sure the study is fair and the results are true. After the people in the study get their treatment, the researchers will watch and see how they do. They will check if their muscles are less stiff and if they have any side effects. By looking at the results from both groups, the researchers can find out if the special treatment really helps people with spasticity. Patients who got the "fake" treatment will be eligible to receive the "real" treatment after 6 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-30
• Study First Submitted QC: 2023-09-30
• Study First Posted: 2023-10-06
• Study Start: 2023-10-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Chronic spasticity refractory to medical management or in a patient who cannot receive appropriate medical management mediated by one or more spinal nerve roots
• Age > 16 (if under 18, patients parents must sign consent).

Exclusion Criteria

• Inability to lie supine for simulation & treatment
• Inability to visualize the target nerve on either CT or MRI imaging
• Patients with confirmed pregnancy (all women of child-bearing age with intact uterus & ovaries will be required to undergo a pregnancy test prior to simulation)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Treatment	Sham	No intervention but can crossover after 6 months
SRS Treatment	stereotactic radiosurgery (SRS) dorsal root rhizotomy radiomodulation	-

Primary Outcome Measures

Name	Time	Method
Change in Modified Ashworth Scale	6 months post treatment	Change in the 6-month post-treatment Modified Ashworth Scale (MAS) measure of spasticity, which ranges from 0 (no symptoms) to 4 (worst symptoms)

Secondary Outcome Measures

Name	Time	Method
Change in spasticity-related quality of life (SQoL-6D)	2 years post treatment	Change in spasticity-related quality of life 6-dimensions instrument (SQoL-6D) over two years post-treatment, where the scale ranges from 0 (worst quality of life) to 100 (best quality of life)

Trial Locations

Locations (2)

Centro Diagnostico Italiano; 🇮🇹 Milano, Italy

Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States